EP1987803A2 - Cheville à expansion pour la fixation de tendons - Google Patents

Cheville à expansion pour la fixation de tendons Download PDF

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Publication number
EP1987803A2
EP1987803A2 EP08445018A EP08445018A EP1987803A2 EP 1987803 A2 EP1987803 A2 EP 1987803A2 EP 08445018 A EP08445018 A EP 08445018A EP 08445018 A EP08445018 A EP 08445018A EP 1987803 A2 EP1987803 A2 EP 1987803A2
Authority
EP
European Patent Office
Prior art keywords
arms
graft
fixation
width
expanding
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP08445018A
Other languages
German (de)
English (en)
Other versions
EP1987803A3 (fr
Inventor
Aprihl Saphiro
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Arthrex Inc
Original Assignee
Arthrex Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Arthrex Inc filed Critical Arthrex Inc
Publication of EP1987803A2 publication Critical patent/EP1987803A2/fr
Publication of EP1987803A3 publication Critical patent/EP1987803A3/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • A61B2017/0437—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being resilient or spring-like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
    • A61F2002/0852—Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0876—Position of anchor in respect to the bone
    • A61F2002/0882—Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone

Definitions

  • the present invention relates to apparatus and methods for surgically anchoring replacement tendon constructs.
  • a tissue graft is attached to the bone to facilitate regrowth and permanent attachment.
  • fixation devices including sutures, screws, staples, wedges, and plugs have been used in the past to secure soft tissue to bone.
  • the graft is fixed to the bone by driving the screw into a blind hole or a tunnel in the bone while trapping the end of the graft between the screw and the bone tunnel.
  • the graft is simply pinned against the bone using staples or sutures tied around the end of the graft to the bone.
  • the present invention overcomes disadvantages of the prior art, such as those noted above, by providing an expanding device or bolt for soft tissue fixation (for example, for tendon fixation).
  • the expanding device or bolt is a flexible "A-Frame" that is configured to collapse when pushed in a first direction (for example, when pushed antegrade) within a tunnel or socket, and to expand and engage adjacent tissue (for example, bone of the tunnel or socket) when pulled in a second direction (for example, when pulled retrograde).
  • Fixation devices of the flexible "A-Frame" device (for example, two arms of resilient material) are configured to expand diametrically to achieve interference fixation of soft tissue (for example, graft tendon) in a bone tunnel.
  • the present invention also provides a graft fixation surgical method employing an expanding device, comprising the steps of: (i) pre-forming a hole or tunnel (for example, a femoral or tibial tunnel); (ii) attaching a graft (for example, a soft tissue graft) to the expanding device or expanding bolt to form a graft/expanding device assembly; (iii) inserting the graft/expanding device assembly into the tunnel in an antegrade manner, so that the expanding device is in a collapsed state; and (iv) pulling the graft/expanding device assembly in a retrograde manner, so that the expanding device expands (in the fully deployed configuration) and engages bone to resist pullout.
  • a hole or tunnel for example, a femoral or tibial tunnel
  • attaching a graft for example, a soft tissue graft
  • inserting the graft/expanding device assembly into the tunnel in an antegrade manner, so
  • FIGS. 1(a)-(f) illustrate various views of a fixation device according to the present invention
  • FIG. 2 is a perspective view of the fixation device of the present invention
  • FIG. 3 is another perspective of the fixation device of the present invention.
  • FIG. 4 illustrates a graft tendon assembled to a fixation device according to the present invention.
  • the expanded device (bolt) of the present invention is configured to expand diametrically to achieve interference fixation of a graft tendon in a bone tunnel.
  • the graft for example, tendon graft
  • a passing strand for example, suture
  • the fixation devices is configured to expand radially to achieve interference fixation of soft tissue (for example, graft tendon) in a bone tunnel.
  • Expanding device or bolt 100 comprises a body 50 in the shape of a flexible "A-Frame" that is configured to collapse when pushed in a first direction (for example, when pushed antegrade) within a tunnel or socket, and to expand and engage adjacent tissue (for example, bone of the tunnel or socket) when pulled in a second direction (for example, when pulled retrograde and in an axial direction).
  • A-Frame a flexible "A-Frame” that is configured to collapse when pushed in a first direction (for example, when pushed antegrade) within a tunnel or socket, and to expand and engage adjacent tissue (for example, bone of the tunnel or socket) when pulled in a second direction (for example, when pulled retrograde and in an axial direction).
  • body 50 of the expanding device 100 comprises a main elongated frame 52 having a generally rectangular configuration, and an inner part 54 also with a generally rectangular configuration and located fully within the perimeter of the main frame 52.
  • the surface area A ( FIG. 3 ) of inner part 54 is about 2/3 smaller than that of the main frame 52, to reduce the amount of material (for example, PLLA) employed for the formation of the device 100 and to permit secure fixation of the free ends of a ligament graft that is to be seated within the sides of the inner part 54 and/or within window or aperture 55.
  • the thickness "t" ( FIG. 2 ) of the inner part 54 is smaller than the thickness "T" ( FIG. 2 ) of the main frame 52 (for example, about half the thickness "T"), also to allow enhanced seating of the free ends of a graft ligament when used in conjunction with the fixation device.
  • a plurality of through holes 70 are provided within the inner part 54 (extending from un upper surface to a lower surface of the inner part 54) to allow a secure suturing to the graft and bone growth infiltration.
  • the expanding device 100 is sutured to a graft (for example, a tendon or ligament graft) with multiple holes to fixate the graft free ends.
  • the multiple holes 70 (three in the exemplary embodiment shown in FIGS. 2 and 3 ) also reduce the amount of material (for example, PLLA) employed for the formation of the device 100 and allow accelerated tissue/bone ingrowth.
  • Fixation devices 60a, 60b that are configured to expand diametrically and radially to achieve interference fixation of soft tissue (for example, graft tendon) in a bone tunnel.
  • fixation devices 60a, 60b comprise a plurality of arms or flanges (for example, two arms as shown in FIGS. 1-3 ) formed of resilient material, that allows the arms to expand and engage tissue.
  • each of the fixation devices 60a, 60b has a width which is about equal to the width or thickness "T" of the main frame 52.
  • the arms are configured to expand radially and to increase the width W1 of the bolt (corresponding to the collapsed state) to a width W2 (corresponding to the expanded state) ( FIGS. 1(d) and 1(f) ).
  • body 50 and fixation devices 60 of the "A-Frame" device 100 have the profile and configuration shown in FIGS. 1-3 , these features may have various configurations that allow the device to be maneuvered axially in a first direction, and to spread open and expand when urged in a second (for example, an opposite) direction. Additional fixation can be provided using suture.
  • Expanding devices or anchors according to the present invention can be used for arthroscopic procedures such as ligament repairs.
  • the devices are also advantageous for open and mini-open surgical procedures. Specific examples of applicable procedures include cortical bone-soft tissue fixation, Bankart and SLAP shoulder repairs.
  • a surgical method employing an expanding device or bolt such as the expanding bolt 100 of FIGS. 1-3 , generally includes pre-forming a hole or tunnel (for example, a femoral tunnel) for insertion of the device.
  • the expanding device 100 (attached to a graft) is then inserted into the hole/tunnel and then expanded.
  • FIG. 4 illustrates an exemplary graft/plug assembly 200 comprising at least one graft tendon construct 199 tied to expanding plug 100 according to a method of the present invention.
  • the graft construct 199 is formed as a continuous loop sutured together around expanding plug 100 (on a graft workstation, for example).
  • the expanding plug 100 spaces the tendon strands apart to create a double-bundle configuration.
  • Suture 75 is used to maintain placement of the tendon graft strands around the plug 100 and to create a desired length graft.
  • the graft/plug assembly 200 is installed into a tunnel (for example, femoral tunnel) by guiding the assembly oriented with graft-end 7 ( FIG. 4 ) entering the tunnel and pulling the assembly up into the tunnel (in a first direction) using a passing strand (for example, suture 150). While the graft/plug assembly 200 is advanced in the first direction (i.e., pulled up into the tunnel or pushed up antegrade), the plug 100 is in the unexpanded configuration, with resilient arms 60a, 60b in the collapsed state, to allow the graft/plug assembly 200 to advance through the bone tunnel.
  • a tunnel for example, femoral tunnel
  • a passing strand for example, suture 150
  • a second step in conducted in which graft end 7 is pulled in a second direction (i.e., the joint line end 9 is pulled in a second direction, using another set of passing strands (for example, suture strands)).
  • the load is applied in an opposite direction (for example, in a retrograde manner) to that described above for the initial first step when the plug is in a collapsed or undeployed configuration. Pulling on joint-line end 9 of the graft/plug assembly 200 in the second direction allows the deployment of expanding plug 100.
  • Joint-line end 9 of expansion plug 100 is urged by the load being applied by pulling on the passing suture to allow the resilient arms 60a, 60b to deploy from the unexpanded configuration to the expanded or deployed configuration shown in FIGS. 1-3 .
  • Resilient arms 60a, 60b expand diametrically and radially to achieve interference fixation of soft tissue (for example, graft tendon) in the bone tunnel. In this manner, the arms will apply a lateral and a radial force, and will resiliently engage the surrounding bone to prevent the plug from being withdrawn from the bone tunnel in the direction of its entry.
  • Resilient arms 60a, 60b may be also formed out of a pseudoelastic shape memory alloy such as a nickel titanium alloy (for example, Nitinol).
  • a pseudoelastic shape memory alloy such as a nickel titanium alloy (for example, Nitinol).
  • the width of the plug and looped graft together preferably does not exceed about 10 mm, on average, with a double-wrapped autograft semitendinosis graft or a single tibialis tendon allograft.
  • the width of the plug should be approximately 5 mm expanding to a minimum of 10 mm at body temperature.
  • Maximum resistance of graft pullout in porcine bone sockets equal to the diameter of the graft preferably is not less than 500 N.
  • the present invention provides a low profile construction with the graft looped around the bottom and slots (through holes) on the side to accommodate the graft strands. It is not necessary to enlarge the overall bone tunnel size needed. Additional strands (for example, one to two no. 5 FiberWire sutures) may be attached to the base of the expandable plug for graft passing and backup fixation.
  • the expanding bolt 100 of the present invention is a self-reinforcing structure.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Rheumatology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Rehabilitation Therapy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)
EP08445018A 2007-05-01 2008-04-30 Cheville à expansion pour la fixation de tendons Withdrawn EP1987803A3 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US91528707P 2007-05-01 2007-05-01

Publications (2)

Publication Number Publication Date
EP1987803A2 true EP1987803A2 (fr) 2008-11-05
EP1987803A3 EP1987803A3 (fr) 2009-05-27

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP08445018A Withdrawn EP1987803A3 (fr) 2007-05-01 2008-04-30 Cheville à expansion pour la fixation de tendons

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US (1) US20080275554A1 (fr)
EP (1) EP1987803A3 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMO20100294A1 (it) * 2010-10-22 2012-04-23 Ncs Lab S R L Dispositivo fissatore per fili di sutura da inserire in tessuto osseo.
ITMO20100293A1 (it) * 2010-10-22 2012-04-23 Ncs Lab S R L Dispositivo fissatore per fili di sutura da inserire in tessuto osseo.
GB2490228A (en) * 2011-04-20 2012-10-24 Wolf Gmbh Richard A tendon fixation anchor with through-holes

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8512376B2 (en) 2002-08-30 2013-08-20 Arthrex, Inc. Method and apparatus for internal fixation of an acromioclavicular joint dislocation of the shoulder
US20090234451A1 (en) * 2008-03-12 2009-09-17 Manderson Easton L Method and system for graft ligament attachment
US20090281581A1 (en) 2008-05-06 2009-11-12 Berg Jeffery H Method and device for securing sutures to bones
EP2238944B1 (fr) 2009-03-31 2015-10-21 Arthrex Inc Bouton de suture réglable pour la reconstruction tissulaire
US8439976B2 (en) * 2009-03-31 2013-05-14 Arthrex, Inc. Integrated adjustable button-suture-graft construct with two fixation devices
AU2010236136B2 (en) 2009-04-17 2014-07-10 Shane Barwood Tenodesis system
WO2011005966A2 (fr) * 2009-07-09 2011-01-13 Smith & Nephew, Inc. Ensemble ancrage pour greffe de tissu et instrumentation destinée à être utilisé avec celui-ci
US8956395B2 (en) 2009-07-09 2015-02-17 Smith & Nephew, Inc. Tissue graft anchor assembly and instrumentation for use therewith
EP2455001B1 (fr) 2010-11-17 2020-07-22 Arthrex, Inc. Structures de bouton de suture réglable pour la reconstruction de ligaments
EP3527144B1 (fr) 2010-11-17 2023-12-13 Arthrex Inc Structure de bouton de suture réglable pour la réparation de la syndesmose de la cheville
EP2455040B1 (fr) 2010-11-17 2015-03-04 Arthrex, Inc. Structure de bouton de suture réglable pour stabilisation sans noeuds de grasset de ligament croisé défectueux crânien
GB2504612B (en) 2011-05-09 2014-09-24 Rolls Royce Plc An apparatus for supporting a tool in an assembled apparatus
US9301745B2 (en) 2011-07-21 2016-04-05 Arthrex, Inc. Knotless suture constructs
US9332979B2 (en) 2011-07-22 2016-05-10 Arthrex, Inc. Tensionable knotless acromioclavicular repairs and constructs
US9107653B2 (en) 2011-09-22 2015-08-18 Arthrex, Inc. Tensionable knotless anchors with splice and methods of tissue repair
US8834523B2 (en) * 2011-09-29 2014-09-16 Smith & Nephew, Inc. Attachment device to attach tissue graft
US10245016B2 (en) 2011-10-12 2019-04-02 Arthrex, Inc. Adjustable self-locking loop constructs for tissue repairs and reconstructions
US9615821B2 (en) 2011-12-09 2017-04-11 Arthrex, Inc. Tensionable knotless anchor systems and methods of tissue repair
US9737292B2 (en) 2012-06-22 2017-08-22 Arthrex, Inc. Knotless suture anchors and methods of tissue repair
US9901335B2 (en) 2014-07-10 2018-02-27 Maxwell Choongwon Park Method and apparatus for securing soft tissue to bone
US10265060B2 (en) 2015-08-20 2019-04-23 Arthrex, Inc. Tensionable constructs with multi-limb locking mechanism through single splice and methods of tissue repair
US10335136B2 (en) 2015-08-20 2019-07-02 Arthrex, Inc. Tensionable constructs with multi-limb locking mechanism through single splice and methods of tissue repair
US10085830B2 (en) * 2016-05-13 2018-10-02 Medos International Sarl Device, system, and method for delivery of a tissue fixation device
US20220354482A1 (en) * 2019-08-19 2022-11-10 Zurimed Technologies Ag Implantable suspension device, assembly device and method for assembling an implantable suspension device
DE102020105381A1 (de) 2020-02-28 2021-09-02 H & B Electronic Gmbh & Co. Kg Klemmelement und Setzanordnung

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5505735A (en) * 1993-06-10 1996-04-09 Mitek Surgical Products, Inc. Surgical anchor and method for using the same
US5372604A (en) * 1993-06-18 1994-12-13 Linvatec Corporation Suture anchor for soft tissue fixation
US6152928A (en) * 1999-03-02 2000-11-28 Ethicon, Inc. Ligament fixation device and method
DE10222047B4 (de) * 2002-05-13 2007-04-12 Aesculap Ag & Co. Kg Implantat

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMO20100294A1 (it) * 2010-10-22 2012-04-23 Ncs Lab S R L Dispositivo fissatore per fili di sutura da inserire in tessuto osseo.
ITMO20100293A1 (it) * 2010-10-22 2012-04-23 Ncs Lab S R L Dispositivo fissatore per fili di sutura da inserire in tessuto osseo.
WO2012052891A1 (fr) * 2010-10-22 2012-04-26 Ncs Lab S.R.L. Dispositif de fixation de fils de suture à insérer dans un tissu osseux
US10335135B2 (en) 2010-10-22 2019-07-02 Ncs Lab S.R.L. Fixing device for suture threads to be inserted into a bone tissue
GB2490228A (en) * 2011-04-20 2012-10-24 Wolf Gmbh Richard A tendon fixation anchor with through-holes
GB2490228B (en) * 2011-04-20 2018-03-14 Wolf Gmbh Richard A tendon fixation anchor

Also Published As

Publication number Publication date
EP1987803A3 (fr) 2009-05-27
US20080275554A1 (en) 2008-11-06

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